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FDA Unveils Proposed Testing Regulations for Asbestos Detection in Cosmetics


The agency has stated that this regulation will help safeguard individuals using products containing talc from potential exposure to this recognized carcinogen.

On December 26, the U.S. Food and Drug Administration (FDA) put forward a federal rule designed to shield consumers of talc-containing cosmetic items from possible asbestos exposure.

If this rule is implemented, it will mandate that cosmetic products with talc undergo standardized testing to confirm the absence of asbestos, a substance known to cause cancer.

According to the proposed rule, manufacturers of these talc-inclusive cosmetic products will need to utilize techniques like Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM) to ascertain the presence of asbestos in their offerings.

Alternatively, the FDA allows manufacturers to produce a certificate of analysis from their talc supplier as validation of safety.

Evidence connecting cancer to talc has been inconclusive, with some research indicating a marginally higher cancer risk while others show no significant increase, as noted by the American Cancer Society.
“For many years, the FDA has actively sampled and tested talc-containing cosmetics for asbestos, collaborating with federal partners to minimize the risk of consumer exposure to asbestos—a recognized human carcinogen—in contaminated talc products,” remarked Linda Katz, Director of the FDA Office of Cosmetics and Colors, in a December 26 statement.

Katz indicated that the FDA has meticulously evaluated the scientific data and intricate policy matters concerning the detection of asbestos in talc and talc-containing products.

“We are confident that the proposed testing techniques are suitable for identifying asbestos, thus contributing to the safety of talc-containing cosmetic products,” she affirmed.

The proposed regulation includes clauses requiring manufacturers to maintain documentation to demonstrate adherence to the new standards. Should manufacturers neglect these testing and record-keeping mandates, the FDA would have the authority to classify their products as “adulterated” under the Federal Food, Drug, and Cosmetic Act.

The term “adulterated” signifies that the product(s) in question are “defective, unsafe, unproven safe, filthy, or created under unsanitary conditions,” or manufactured in ways that do not comply with Current Good Manufacturing Practice standards, as defined by the FDA.
This proposal surfaces amidst ongoing legal challenges faced by pharmaceutical leader Johnson & Johnson regarding alleged connections between its talc products, such as baby powder, and ovarian cancer. Meanwhile, cosmetics company Avon is also dealing with lawsuits concerning claims of asbestos contamination in its talc-based products.

Both companies maintain that these accusations lack merit and are actively pursuing resolutions to the lawsuits.

Talc, a naturally occurring mineral, is commonly used in numerous cosmetics and personal care items due to its moisture-absorbing properties, ability to prevent clumping, and capacity to enhance product texture.

Asbestos, a mineral fiber extracted from underground deposits, can be found in the same geological formations as talc, creating a potential risk for cross-contamination. For this reason, the FDA emphasizes the necessity of testing for asbestos in cosmetic products containing talc.

The FDA is inviting public feedback on this proposed rule for 90 days, after which it will review the comments as part of finalizing the regulation.

The Epoch Times reached out to Johnson & Johnson and Avon for their comments but did not receive any responses by the time of publication.

Reuters and the Associated Press contributed to this report.



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